Carbon Dioxide (CO2) Measurement With a CO2/O2 Guedel Airway

Measurement of Expired Carbon Dioxide: Comparison of a Modified CO2/O2 Guedel Airway With a Nasal Cannula in Sedated Children Aged 4-24 Months

This trial compares capnographic signals using a modified CO2/O2 Guedel airway with a CO2/O2 nasal cannula without and with oxygen supply in sedated children aged 4 - 24 months.

Study Overview

• Status: Withdrawn
• Conditions: Breathing Stop
• Intervention / Treatment: Device: modified Guedel airway

Detailed Description

Sedation of pediatric patients is frequently jeopardized by respiratory adverse events such as central and/or obstructive apnea resulting in hypoxemia. Various factors such as patient comorbidities, medication and inconsistent physiologic monitoring are known to contribute to or facilitate adverse events during sedation. Therefore, monitoring of breathing by capnography is recommended and has become common standard e.g. by the use of a CO2/O2 nasal cannula.

However, capnography derived from CO2/O2 nasal cannulas may be impaired and these impairments are exaggerated in infants based on their physiologic characteristics (small tidal volumes, high respiratory rates).

To overcome these impairments, the investigators developed a modified CO2/O2 Guedel airway including a CO2 sampling port at the tip of the airway. In a previous study, significantly more accurate capnographic signals resulted compared with measurements derived from a nasal cannula when using a modified CO2/O2 Guedel airway in a model of a breathing 6-month-old manikin.

The aim of the study is to examine the accuracy of capnographic measurements of the modified CO2/O2 Guedel airway in comparison with measurements from a CO2/O2 nasal cannula in sedated children aged 4 - 24 months.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel Stadt
    • Basel, Basel Stadt, Switzerland, 4056
      • University children´s hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 months to 2 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Term born infants aged 4 to 24 months
• Physical status according classification I or II (American Society of Anaesthesiologists (ASA))
• Scheduled for elective diagnostic/therapeutic procedures or surgery under sedation/anaesthesia
• Informed Consent as documented by signature of the parents or legal caregiver

Exclusion Criteria:

• syndrome that affects the airway anatomy
• Physical status according classification III or IV (American Society of Anaesthesiologists (ASA))
• Upper respiratory tract infection at present or within the last two weeks before the study
• Previous enrolment into the current study
• Known hypersensitivity or allergic reactions to midazolam, nitrous oxide (N2O), Propofol or Sevoflurane.
• Positive Family History for malignant hyperthermia, Morbus Pompe or ophthalmic operations with gas injection or Sinus- or inner ear surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Nasal cannula / Guedel; Record of capnography using a standard nasal cannula followed by use of a modified Guedel airway	Device: modified Guedel airway; Monitoring of breathing
EXPERIMENTAL: Guedel / nasal cannula; Record of capnography using a modified Guedel airway followed by use of a standard nasal cannula	Device: modified Guedel airway; Monitoring of breathing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
end-tidal carbon-dioxide concentration (etCO2)	Difference between capillary and maximum etCO2 sampled via a modified CO2/O2 Guedel airway versus a CO2/O2 nasal cannula	90 seconds

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of end-tidal carbon-dioxide concentration (etCO2) according to different oxygen flows (O2)	Effect of O2 administration on etCO2 measurement	90 seconds

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: University Children's Hospital Basel
• Investigators: Principal Investigator: Thomas Erb, Prof. Dr. MD, UKBB

Publications and helpful links

General Publications

• Moll J, Anagnostopoulou P, Frei FJ, Erb TO. A modified CO2/O2 Guedel airway improves capnographic accuracy compared with a CO2/O2 nasal cannula: An infant manikin study. Eur J Anaesthesiol. 2018 Aug;35(8):566-572. doi: 10.1097/EJA.0000000000000818.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2020
• Primary Completion (ANTICIPATED): January 1, 2021
• Study Completion (ANTICIPATED): January 1, 2021

Study Registration Dates

• First Submitted: August 7, 2018
• First Submitted That Met QC Criteria: August 15, 2018
• First Posted (ACTUAL): August 17, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 6, 2020
• Last Update Submitted That Met QC Criteria: November 4, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Pediatric; nasal cannula; Capnography; Guedel airway
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Apnea
• Other Study ID Numbers: UKBB_Anae_CO2_Gued_Feas

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No